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Evaluation of clinical outcomes during 12 months after inclisiran initiation in patients after STEMI/non-STEMI in real-world settings in Russia. It is also planned to study the therapy effect on the lipid profile characteristics, its safety, the state of atherosclerotic plaques according to carotid ultrasound, the frequency of hospitalizations and the need for intensive follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STEMI/Non-STEMI | Patients with inclisiran initiation in 14 ± 5 days after STEMI/non-STEMI |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with Atherosclerotic Cardiovascular Disease (ASCVD) events registered within 12 months after inclisiran initiation in addition to basic therapy | Number of patients with Atherosclerotic Cardiovascular Disease (ASCVD) events (cardiac death, nonfatal MI, nonfatal ischemic stroke, and hospitalization for unstable angina) registered within 12 months after the start of inclisiran therapy prescribed in addition to basic LLT | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change and absolute change in lipid profile parameters | Change and absolute change in lipid profile parameters (total cholesterol, LDL-C, HDL-C, non-HDL-C, triglycerides, lipoprotein (a)) at 3, 9, and 12 months | Baseline, month 3, month 9, month 12 |
| Change and absolute change in lipid profile parameters in patients subgroups |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include patients with inclisiran initiation in 14 ± 5 days after STEMI/non-STEMI. Index event is a first diagnosed STEMI/non-STEMI.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Cheboksary | 428000 | Russia | ||
| Novartis Investigative Site |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Change and absolute change in lipid profile parameters at 3, 9, and 12 months in each of the 3 groups of patients identified on the basis of therapy and LDL-C level at admission:
|
| Baseline, month 3, month 9, month 12 |
| Change in LDL-C level | Change in LDL-C level at Day 28 from baseline | Baseline, Day 28 |
| The proportion of patients who maintain the target LDL-C level | The proportion of patients who maintain the target LDL-C level achieved after 3 months throughout the study period (12 months) | Month 3, Month 12 |
| The proportion of patients who achieved the target LDL-C level of < 1.4 mmol/L | The proportion of patients who achieved the target LDL-C level of < 1.4 mmol/L at Day 28 and at 12 months | Day 28 , Month 12 |
| The proportion of patients with progression and regression/no changes in atherosclerotic plaque | The proportion of patients with progression and regression/no changes in atherosclerotic plaque determined on the basis of changes in its maximum height (mm) by carotid ultrasound at 12 months compared to 3-5 days after ACS (Acute Coronary Syndrome) | Baseline, Month 12 |
| Number (%) of patients who achieved the target LDL-C level of < 1.4 mmol/L and with change in the maximum plaque height (mm) | The correlation between the achievement of the target LDL-C level of < 1.4 mmol/L and a change in the maximum plaque height (mm) is going to be measured. | 12 months |
| Total number of patients with adverse events (AE) in general, treatment-emergent AE (TEAEs), and serious adverse events (SAE) | Total number of patients with adverse events (AE) in general, treatment-emergent AE (TEAEs), and serious adverse events (SAE) at 3, 9, and 12 months | Month 3, Month 9, Month 12 |
| The number of patients who discontinued inclisiran therapy due to AEs | The number of patients who discontinued inclisiran therapy due to AEs at 3, 9, and 12 months | Month 3, Moth 9, Month 12 |
| The number of patients re-hospitalized for CV events during the year | The number of patients re-hospitalized for cardiovascular (CV) events during the year | 12 months |
| The number of patients re-hospitalized during the year for scheduled and unscheduled revascularization | The number of patients re-hospitalized during the year for scheduled and unscheduled revascularization | 12 months |
| Number of patients who sought emergency care after the baseline visit | Number of patients who sought emergency care after the baseline visit | 12 months |
| The number of patients placed under dispensary observation | The number of patients placed under dispensary observation | 12 months |
| Number of days from the date of hospital discharge to place under dispensary observation | Number of days from the date of hospital discharge to place under dispensary observation | 12 months |
| Recruiting |
| Grozny |
| 364051 |
| Russia |
| Novartis Investigative Site | Recruiting | Kemerovo | 650002 | Russia |
| Novartis Investigative Site | Recruiting | Khanty-Mansiysk | 628012 | Russia |
| Novartis Investigative Site | Recruiting | Moscow | 105203 | Russia |
| Novartis Investigative Site | Recruiting | Moscow | 119607 | Russia |
| Novartis Investigative Site | Recruiting | Moscow | 121552 | Russia |
| Novartis Investigative Site | Recruiting | Novosibirsk | 630051 | Russia |
| Novartis Investigative Site | Recruiting | Penza | 440026 | Russia |
| Novartis Investigative Site | Recruiting | Petrozavodsk | 185019 | Russia |
| Novartis Investigative Site | Recruiting | Rostov-on-Don | 344010 | Russia |
| Novartis Investigative Site | Recruiting | S Petersburg | 192242 | Russia |
| Novartis Investigative Site | Recruiting | Samara | 443070 | Russia |
| Novartis Investigative Site | Recruiting | Syktyvkar | 167981 | Russia |
| Novartis Investigative Site | Recruiting | Tomsk | 634009 | Russia |
| Novartis Investigative Site | Recruiting | Ulan-Ude | 670031 | Russia |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |